MCG Diagnostics 700023-906

GUDID B3687000239060

Express Series CCM

MEDICAL GRAPHICS CORPORATION

Cardiopulmonary stress exercise monitoring system
Primary Device IDB3687000239060
NIH Device Record Keycc2d069b-766d-4605-91e2-a2cb97c4e113
Commercial Distribution StatusIn Commercial Distribution
Brand NameMCG Diagnostics
Version Model Number700023-906
Catalog Number700023-906
Company DUNS094045622
Company NameMEDICAL GRAPHICS CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810016250012 [Primary]
HIBCCB3687000239060 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BZLComputer, Oxygen-Uptake

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-11
Device Publish Date2019-02-23

On-Brand Devices [MCG Diagnostics]

B3687000239060Express Series CCM
00810016251620PREVENT II FILTER-OVAL-WHITE
00810016250289FILTER KIT 2

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